DEPUY FEMORAL HEADS by DEPUY ORTHOPAEDICS, INC.

Total hip arthroplasty is intended to provide increased patient mobility and reduce pain by replacing the damaged hip joint articulation in patients where there is evidence of sufficient replacing the unmaged the components. Total hip replacement is indicated in the following conditions:

A severely painful and/or disabled joint from osteoarthritis, traumatic arthritis, rheumatoid arthritis, or congenital hip dysplasia.
Avascular necrosis of the femoral head.
Acute traumatic fracture of the femoral head or neck.
Failed previous hip surgery including joint reconstruction, internal fixation, arthrodesis, hemiarthroplasty, surface replacement arthroplasty, or total hip replacement.
Certain cases of ankylosis.

Device Description

The DePuy Ceramic Femoral Heads are available in a diameter of 28mm, with various offset options. The internal bore which is designed to interlock with the external taper on DePuy femoral stems is available in two variations. The Ceramic Heads are intended to attach to femoral stems, thereby providing the femoral articular surface of a total hip replacement. The DePuy Ceramic Femoral Heads are made from an alumina composite material.

AI/ML Overview

This submission describes the DePuy Femoral Heads, a ceramic femoral ball prosthesis, and its substantial equivalence to previously cleared devices.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance
Substantial Equivalence	The DePuy Ceramic Femoral Heads are identical in design and indications to ceramic femoral heads previously cleared. Testing has shown that minor adjustments do not affect the performance of the device. (This implies that the device meets the performance characteristics of its predicate, which is the implicit acceptance criterion for 510(k) submissions focusing on substantial equivalence.)

Acceptance Criteria

Reported Device Performance

Substantial Equivalence

The DePuy Ceramic Femoral Heads are identical in design and indications to ceramic femoral heads previously cleared. Testing has shown that minor adjustments do not affect the performance of the device. (This implies that the device meets the performance characteristics of its predicate, which is the implicit acceptance criterion for 510(k) submissions focusing on substantial equivalence.)

2. Sample Size Used for the Test Set and Data Provenance

The document does not specify a distinct "test set" in the context of an AI/ML device. Instead, it refers to "testing" that was performed to demonstrate that minor adjustments to the device did not affect its performance. This suggests bench testing or mechanical testing rather than human performance studies with a specific data set.

Sample Size: Not specified.
Data Provenance: Not specified, but likely from internal lab testing given the nature of the device and the claim of "identical in design" to a predicate. It would be retrospective in the sense that the design changes were already made and then tested.

3. Number of Experts Used to Establish Ground Truth and Qualifications of Experts

This information is not applicable as the device is a ceramic femoral head (a physical orthopedic implant), not an AI/ML device that requires expert-established ground truth for its performance evaluation in this context. The "truth" here relates to the mechanical and material properties meeting established standards or being equivalent to a predicate.

4. Adjudication Method for the Test Set

This is not applicable for the same reasons as point 3.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

This is not applicable as the device is a physical orthopedic implant and not an AI-assisted diagnostic or therapeutic tool for human readers.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

This is not applicable as the device is a physical orthopedic implant, not an algorithm.

7. Type of Ground Truth Used

The "ground truth" implicitly used for this device would be:

Mechanical and material property specifications: The device's physical properties (e.g., strength, wear resistance, biocompatibility) are expected to meet established industry standards for ceramic femoral heads and/or match those of the legally marketed predicate devices.
Performance of predicate device: The benchmark for performance is the known and accepted performance of the predicate ceramic femoral heads currently on the market.

8. Sample Size for the Training Set

This is not applicable as the device is a physical orthopedic implant. There is no training set in the context of machine learning. The design and manufacturing processes are refined through engineering principles and iterative testing, not through AI training on a dataset.

9. How the Ground Truth for the Training Set Was Established

This is not applicable as there is no training set. The "ground truth" for the development of such a device would be based on engineering design principles, material science, biomechanical requirements for hip implants, and compliance with relevant ISO standards for medical devices and materials.

Summary

{0}------------------------------------------------

011533 page 1 of 1

Image /page/0/Picture/1 description: The image shows the logo for DePuy, a Johnson & Johnson company. The logo consists of a solid black circle to the left of the name "DePuy" in a bold, sans-serif font, also in black. Below the name, in a smaller font, is the text "a Johnson-Johnson company". The logo is simple and professional, conveying a sense of stability and trust.

SUMMARY OF SAFETY AND EFFECTIVENESS JAN 2 8 2002 DePuy Orthopaed PO Box 988 DePuy Orthopaedics, Inc. NAME OF FIRM: 700 Orthopaedic Drive P.O. Box 988 Warsaw, Indiana 46581-0988 USA 700 Orthopaedic Drive Tel: +1 (219) 267 8143 Warsaw, IN 46581-0988 Fax: +1 (219) 267 7196 510(k) CONTACT: Janet G. Johnson Group Leader. Regulatory Affairs TRADE NAME: DePuy Femoral Heads COMMON NAME: Ceramic Femoral Ball Prosthesis CLASSIFICATION: 888.3353 Hip joint metal/ceramic/polymer, semiconstrained cemented or nonporous uncemented prosthesis DEVICE PRODUCT CODE: 87 LZO SUBSTANTIALLY EQUIVALENT DEVICES: Ceramic Articul/eze Femoral Balls, S-ROM Ceramic Femoral Heads

DEVICE DESCRIPTION AND INTENDED USE:

BASIS OF SUBSTANTIAL EQUIVALENCE:

The DePuy Ceramic Femoral Heads are identical in design and indications to the ceramic femoral heads that were cleared previously. Testing has shown that the minor adjustments do not affect the performance of the device.

{1}------------------------------------------------

Image /page/1/Picture/1 description: The image shows the seal of the U.S. Department of Health and Human Services. The seal features a stylized eagle with its wings spread, symbolizing protection and service. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the eagle, indicating the department's name and national affiliation.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Janet G. Johnson Group Leader, Regulatory Affairs DePuy Orthopaedics, Inc. P.O. Box 988 700 Orthopaedic Drive Warsaw, Indiana 46581-0988

JAN 2 8 2002

Re: K011533 Trade/Device Name: DePuy Femoral Heads Regulation Number: 21 CFR 888.3353 Regulation Name: Hip joint metal/ceramic/polymer, semi-constrained cemented or nonporous uncemented prosthesis Regulatory Class: II Product Code: LZO Dated: November 9, 2001 Received: November 13, 2001

Dear Ms. Johnson:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

{2}------------------------------------------------

Page 2 - Ms. Janet G. Johnson

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Mark N. Millman

Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{3}------------------------------------------------

page 1 of 1

510(k) Number (if known) KO11533

Device Name DePuy Femoral Heads

Indications for Use:

Total hip arthroplasty is intended to provide increased patient mobility and reduce pain by replacing the damaged hip joint atticulation in patients where there is evidence of sufficient replacing the unmaged the components. Total hip replacement is indicated in the following conditions:

1. A severely painful and/or disabled joint from osteoarthritis, traumatic arthritis, rheumatoid arthritis, or congenital hip dysplasia.
1. Avascular necrosis of the femoral head.
1. Acute traumatic fracture of the femoral head or neck.
1. Failed previous hip surgery including joint reconstruction, internal fixation, arthrodesis, hemiarthroplasty, surface replacement arthroplasty, or total hip replacement.
1. Certain cases of ankylosis.

Concurrence of CDRH, Office of Device Evaluation

/ Mark A. Melkerson

Division Sign-Off) (Division of General, Restorative and Neurological Devices

eurological Device

K011533

Number

510(k) Number

Prescription Use (Per 21 CFR 801.109)

Over-The Counter Use

00004

Regulation Number and Section

§ 888.3353 Hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis.

(a)
Identification. A hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis is a device intended to be implanted to replace a hip joint. This device limits translation and rotation in one or more planes via the geometry of its articulating surfaces. It has no linkage across-the-joint. The two-part femoral component consists of a femoral stem made of alloys to be fixed in the intramedullary canal of the femur by impaction with or without use of bone cement. The proximal end of the femoral stem is tapered with a surface that ensures positive locking with the spherical ceramic (aluminium oxide, A12 03 ) head of the femoral component. The acetabular component is made of ultra-high molecular weight polyethylene or ultra-high molecular weight polyethylene reinforced with nonporous metal alloys, and used with or without bone cement.(b)
Classification. Class II.